Dispensing device for solid-form pharmaceutical preparations



4, 1966 R. D. KAUFMAN ETAL 3,276,573

DISPENSING DEVICE FOR SOLID-FORM PHARMACEUTICAL PREPARATIONS Filed Jan.21, 1965 2 Sheets-Sheet l 6044a, C. /?W ATTORNEY Oct. 4, 1966 R. D.KAUFMAN ETAL 3,276,573

DISPENSING DEVICE FOR SOLID-FORM PHARMACEUTICAL PREPARATIONS Filed Jan.21. 1965 2 Sheets-Sheet 2 INVENTORS.

A TTORNEY United States Patent 3,276,573 DISPENSING DEVICE FORSOLID-FORM PHARMACEUTICAL PREPARATIONS Richard D. Kaufman, ClarendonHills, and Robert D. Gilmore, Northbrook, Ill., assignors to G. D.Searle & Co., Chicago, 111., a corporation of Delaware Filed Jan. 21,1965, Ser. No. 426,768 6 Claims. (Cl. 206--42) This application is acontinuation-in-part of our patent application Serial No. 376,763, filedJune 22, 1964, now abandoned, with which this application copended.

The present invention relates to dispensing means for pharmaceuticalpreparations in solid dosage form and similar materials, and, moreparticularly, to devices. from which such materials are dispensed in aprogram for administration and use thereof according to daily and othertime-related schedules.

As is well known, certain pharmaceutical preparations are frequentlyprescribed for or recommended to be used by patients on definite dosageschedules over relatively lengthy time periods but at relativelyinfrequent intervals, and careful adherence to such dosage schedules isessential or highly desirable. However, a patient may experienceuncertainty, confusion or other difiicu-lty in hav ing and retainingclearly in mind when the next previous tablet had been used or the nextsubsequent tablet is to be used, or when a course of scheduledmedication is to begin or end. For example, under a regime calling forthe total of six tablets to be administered serially at two hourintervals, most patients will be likely to remember and know the correcttimes to administer each such tablet; on the other hand, under a regimecalling for the total of twenty tablets at the rate of one tablet perday, many patients may be apt to forget whether, on any particular dayduring the twenty, a tablet was used or omitted. In the lattersituation, such patients may either unintentionally elide one or moredays or, conversely, use more than one tablet on a single day. Suchdepartures from the dosage schedule are likely to impair or defeat thepurpose of the tablets and are uneconomic. With the present inventionsuch omissions, excesses, and the uncertainty in which they are founded,are substantially obviated.

An object of the invention is to provide a device wherefrom solid formpharmaceutical preparations may be conveniently and safely dispensed andwhich affords a graphic and readily understandable chronologic schedulefor the time-spaced administration of such pharmaceutical preparations.The invention serves both record-making'and reminding functions relativeto when pharmaceutical preparations have been and are to be dispensed.The

invention enables patients easily and with confidence and assurance tofollow and adhere to a prescribed dosage schedule and to know when acycle or course of medication is to commence and terminate.

Another object of the invention is to afford a reusable structure forthe programmed dispensing of tablets and similar pharmaceuticalpreparations. Although, as hereinafter appears, certain elements areintentionally destructed in the course of their usage, other portionsare readily adaptable to repeated use, thus promoting the economies ofits utilization.

A further object of the invention is to take particular advantage ofrecent advancements in the packaging art relative to solid-formpharmaceutical preparations. Only relatively recently, it is believed,have manufacturing technics been developed which make feasible thepackaging or encapsulation of individual pharmaceutical tablets inindividual deformable blister elements which elements,

after each has received a tablet, are combined with a thin sheet offrangible material, such as metal foil. When 3,276,573- Patentecl Oct.4, 1966 and as so combined, the blister-type elements appear as being onthe frangible sheet, and the combination results in a unit of spaced,tablet-containing chambers, each such chamber having a deformable raisedportion (the blister element) and a readily, but restrictively,rupturable lower portion (the section of the frangible sheet defined bythe blister element). The devices of the present invention enablespecial utilization of tablets so packaged or encapsul ated.

The invention is exceedingly well adapted to the programmed dispensingof oral contraceptive drugs in tablet form, because, with such drugs,the careful adherence to a daily dosage schedule of tablets and, in someinstances, a particular sequence of tablets, is a paramount concern.However, the adaptability of the invention is in no wise limited to thisparticular field.

In the co-pending application for United States Letters Patent SerialNo. 376,763, filed June 22, 1964, now abandoned, and entitled,Dispensing Device for Solid-Form Pharmaceutical Preparations, onepreferred embodiment of a dispensing device of the invention is shown,and the purpose of the instant application is to present that sameembodiment and also, in equal detail, a modified version of theinvention that comprises another preferred embodiment.

The invention is explained in the following description and illustratedin the accompanying drawings:

FIG. 1 is a plan view of one embodiment of the dispenser base.

FIG. 2 is a plan view of the dispenser base of FIG. 1 carrying a supplyof encapsulated pharmaceutical tablets.

FIG. 3 is an exploded sectional elevation view of a dispenser basecarrying a supply of pharmaceutical tablets and a cover, as alongsection 3-3 of FIG. 2.

FIG. 4 and FIG. 6 are enlarged fragment sectional elevations showing thesupply of tablets on a dispenser base.

FIG. 5 depicts the manner in which a tablet is expressed from theinvention.

FIG. 7 is-a plan view of an alternative embodiment of the dispenserbase.

FIG. 8 is a plan view of the planar member bearing a supply ofencapsulated pharmaceutical tab-lets, such planar member havingperipheral conformation corresponding to the base of FIG. 7.

FIG. 9 is a perspective view of the dispenser base of FIG. 7 carryingthe planar member of FIG. 8.

In FIGS. 1-6 numeral 10 is a base (shown as having circular form);numeral 11 represents each of a number of radially and concentricallydisposed holes in base 10; numeral 12 is a central retaining member onand integrally formed with base 10; numeral 13 is the post portion ofretaining member 12; numeral 14 is the overhang arm of retaining member12; numeral 15 represents each of a number of small, concentricallydisposed pegs on base 10; numeral 16 is an opening that may appear nearthe center of base 10; numerals 17, 18, 19, 20, 21, 22 and 23 representchronologic indicia of sequence and periodicity (shown as days of theweek), appearing near the periphery of base 10 and respectively disposedto refer to and indicate a group of radially arranged holes 11; numeral24 is a thin sheet of frangible material (shown in the form of a disc);numeral 25 is a central hole in thin sheet 24, through which the saidthin sheet is adapted to be engaged by retaining member 12; numeral 26represents each of a number of concentrically arranged holes in thinsheet 24, each such hole corresponding with one of the small pegs 15 ofbase 10; numeral 27 represents each of a number of radially disposedblisters, of deformable and transparent material, on one face of thinsheet 24, the relative disposition whereof corresponds with thedisposition of the holes 11 in base numeral 28 is a pharmaceuticaltablet within a blister 27; numeral 29 is an imprinted key, on thinsheet 24, which may be optionally provided to show the first tablet 28to be dispensed; and numeral 30 is a cover which may be optionallyprovided for base 10.

The invention may be utilized simply, with facility, and in a variety ofways. Thus, fully or preassembled as shown in FIG. 2, the invention isimmediately ready to fulfill dispensing, reminding and record-makingfunctions, as of any particular day. To use the embodiment of theinvention with the base 10, a person, on the day when the course ofmedication is to begin, selects the outermost tablet 28 for such dayaccording to the chronologic indicia on base 10, and presses downward onblister 27 containing such tablet. This deforming force may be exertedwith a finger, as depicted in FIG. 5. The pressed blister 27 deforms,and with slight and brief continuation of the deforming force, thet-herewithin tablet 28 ruptures the portion of thin sheet 24 defined bythe said deformed blister and is expressed through the correspondinghole 11. The next day the same procedure is followed with respect of theensuing blister 27 in the same concentric ring of blisters. At the endof a seven day period, the user shifts to the next inner concentric ringof blisters 27. The sequence is repeated again and until the full courseof tablets has been dispensed. At that time, the device may bediscarded, especially when the device has been fabricated for asufficiently low cost to render such disposition economic.

The invention is also Well adapted for other specific modes of use.Although, in the course of utilization, the blisters 27 of thin sheet 24are intentionally destructed, base 10, especially when substantiallyconstructed, is not subject to destruction and can continue to functionindefinitely for many courses of medication. Thus, base 10 can provide apermanent device adapted for refilling of expendable thin sheets 24.Such refilling is readily accomplished, as follows: With cover 30removed and after an expended thin sheet 24 has been removed from base10, a fresh thin sheet 24 is emplaced on base 10 by slipping centralhole 25 of the said thin sheet over and upon retaining member 12 of thesaid base, and rotating the said thin sheet about post portion '13 ofthe said retaining members to the position where the concentricallyarranged holes 26 in the said thin sheet are proximate the small,concentrically disposed pegs '15 of said base. In the embodiment of theinvention shown in FIG. 1, FIG. 2 and FIG. 3, when thin sheet 24 isappropriately prepositioned with respect to base 10, such rotation wouldnever have to exceed twentysix degrees. Then, each hole 26 is pressedover its corresponding peg 15; typically, the holes 26 may be ofslightly smaller diameter than the pegs 15 and the friction between eachholes edge and the peg contributes to retaining thin sheet 24 on base10. The principal function of pegs 15 and the holes 26, however, is toensure correct coordinate positioning of each blister 27 with acorresponding hole 11 in base 10 and with the chronologic indicia, suchas 17, 18, 19, 20, 21, 22 and 23 on base 10. Thin sheet 24 is retainedpositively on and in functional proximity with base 10 by the overhangarm 14 of retaining member 12, the length of such arm being greater thanthe radius of central hole 25 of the said thin sheet. And after base 10is thus refilled, the patient begins a new course of tablets, ashereinbefore described.

In addition to such refilling capability, special provision may be madefor prospective use of the invention. This feature is advantageous incircumstances such as when the first tablet 28 of a particular course orcycle of medication is not to be dispensed until some number of daysafter the user first obtains the dispenser or elements thereof, or whenthe course or cycle of medication is to commence only after someintervening (andperhaps presently indeterminate) event. Under suchcircumstances, when preparing or refilling the device by emplacing thinsheet 24 on base 10, in the manner hereinbefore described, the user mayrefer to and employ imprinted key 29 on thin sheet 24, prospectivelycoordinating such key (and thus the relative position of blisters 27 andtablets 28) with the chronologic indicia of base 10 to indicate thefuture day when the course of medication is to commence. For example,the two legends of imprinted key 29 shown in FIG. 2Day Bleeding Startsand Take First Tabletare specifically intended for situations whentablets 28 are to be dispensed on a daily dosage schedule co-ordinatedwith the menstrual cycle or similar phenomena. Other specificadaptations of such an imprinted keyas, perhaps, a color code further toindicate particular sequence-are readily apparent.

In FIG. 7, FIG. 8 and FIG. 9 of the drawings there is shown analternative preferred embodiment of the dispenser base and thin sheet;for convenience of explanation and to avoid unnecessary repetition,those elements of such alternative embodiment that are identical to orsubstantially identical to corresponding parts of the first describedembodiment are not separately described in this specification and areset forth in FIGS. 7-9 and in the remainder of this specification byprimes of the numerals previously used to describe such parts.

Two modifications characterize base 10 when contrasted with base 10.Base 10 does not have any pegs corresponding to the pegs 15 of base 10,and base 10 does provides several inwardly disposed projectionsdesignated by numeral 40. Also, thin sheet 24' has neither the circularperimeter nor the small holes 26 that characterize thin sheet 24, buthas a number of peripheral indentations designated by numeral 41. Thus,when thin sheet 24 is emplaced about central retaining member 12 (in themanner hereinbefore described), engagement is enabled betweenprojections 40 of base 10 and the extreme portions of thin sheet 24'demarked by indentations 41, and this positive engagement restrains thinsheet 24' from undesired rotational movement relative to base 10 andmaintains blisters 27' in registration with holes 11'. Each projection40 fulfills substantially the corresponding antirotation landcoordinate-positioning function of the pegs 15, and each such projection40 may be regarded as a geometric equivalent of a peg of greatlyenlarged transverse section positioned at a considerably increaseddistance from the central retaining member. Although, in FIG. 7projections 40 are shown as having scallop-like form, and in FIG. 8,indentations 41 are shown as having a conforming fluted form, theseparticular forms are representative only, and other contours that enableengagement between the base and the thin sheet are equally acceptableand with the scope of the invention. In all other respects the manner ofand capability of utilization of the two embodiments of the inventionherein disclosed are the same.

As shown in FIG. 1, opening 16 of base 10 does not have functionalrelationship to the utilization of the invention for its ultimatepurpose; however, inasmuch as base 10 may advantageously be fabricatedof plastic material, by molding, and an opening such as opening 16facilitates the molding process, and particularly the form ing ofretaining member 12, such opening 16 also appears in the drawings.

What is claimed is:

1. A dispensing container for a course of solid-form pharmaceuticaldosage units comprising, in combination, (a) a base having a centralrecess and a plurality of radially arranged apertures therein;

(b) chronologic indicia on the base;

(c) a planar member having a plurality of radially arranged frangiblesections and adapted to be received in the central recess of the baseand selectively emplaced with respect to the chronologic indicia and,when so emplaced, to be carried in fixed position on the base with thefrangible sections of the planar a '5 member in registration with theapertures in the base;

(d) a plurality of erect deformable blisters on one face of the planarmember, each such blister defining a frangible section of the planarmember; and

(e) a solid form pharmaceutical dosage unit within at least one of thedeformable blisters wherefrom such pharmaceutical dosage unit may beexpressed via an aperture in the base, by applying to the blisterexternal force sufficient to rupture the frangible section of the planarmember thereby defined.

2. A dispensing container for a course of pharmaceutical tabletscomprising, in combination,

(a) a base providing araised margin and having a plurality of apertures;

(b) at least one projection extending inwardly from the raised margin ofthe base each such projection and portions of the raised margin defininga central recess;

(c) a retaining element on the base;

(d) a planar member having an indented margin and adapted to beselectively emplaced in the central recess and, when so emplaced, to berestrained from rotational movement relative to the base by marginalengagement with at least one projection thereof and to be held proximatethe base by the retaining element;

(e) a plurality of erect deformable blisters on one face of the planarmember arranged to correspond with the arrangement of apertures in thebase and, when the planar member is emplaced in the central recess, tobe in registration with the said apertures, each such blister defining afrangible portion of the planar member;

(f) a pharmaceutical tablet within at least one of the blisterswherefrom uch tablet, via the aperture with which such blister is inregistration, may be expressed by applying to the blister external forcesufiicient to rupture the frangible portion of the planar member definedby such blister; and

(g) chronologic indicia of sequence and periodicity on the raised marginof the base referable to the apertures therein.

3. A dispensing container for a source of pharmaceutical tabletscomprising, in combination,

(a) a base having a raised outer portion and having a central circularrecess and a plurality of apertures therein, such apertures beingarranged, radially and concentrically, in groups;

(b) chronologic indicia of sequence and periodicity on the raised outerportion of the base respectively proximate and referable to each groupof apertures in radial arrangement;

(c) a central retaining member comprising post and overhang portions inthe circular recess and integrally formed with the base;

(d) a disc, of frangible material, having a central hole therein,adapted to be received about the post portion of the central retainingmember and selectively emplaced in the circular recess with respect thechronologic indicia and to be retained on the base by the overhangportion of the central retaining member;

(e) a plurality of erect deformable blisters on one face of the thindisc, the blisters 'being in radial and concentric arrangement tocorrespond with the arrangement of apertures in the base, such blistersand the thereby defined portions of the thin disc providing a pluralityof chambers;

(f) peg means on the base to fix the thin disc in the selected positionwith respect to the chronologic indicia and the chambers of the thindisc in registration with the apertures in the base;

(g) a pharmaceutical tablet Within at least one of the chamberswherefrom such tablet, via the aperture with which such chamber is inregistration, may be expressed by applying to the blister portion ofsuch chamber external force sufiicient to rupture the portion of thethin disc defined by such blister portion; and

(h) an imprinted key on the thin disc indicating the first tablet to bedispensed.

4. A dispensing container for a course of pharmaceutical tabletscomprising, in combination,

(a) a base providing a raised outer portion and having a central recessand a plurality of apertures therein, such apertures being arrangedradially and concentrically, in groups;

(b) chronologic indicia of sequence and periodicity equidistantly spacedabout the raised outer portion of the base respectively proximate andreferable to each group of apertures in radial arrangement;

(0) a plurality of scallop-like projections extending into the centralrecess from the raised outer portion of the base, each such projectionintermediate two adjacent indicia of periodicity;

(d) a central retaining member comprising post and overhang portions inthe central recess and integrally formed with the base;

(e) a thin sheet of frangible material, having a central hole and aplurality of flute-like peripheral indentations, adapted to beselectively emplaced in the central recess with respect to thechronologic indicia and, when so emplaced, to be held proximate the baseby the central retaining member and to be restrained from rotarymovement relative to the base by engagement of the scallop-likeprojections of the base in the peripheral indentations of the thinsheet;

(f) a plurality of erect deformable blisters on one face of the thinsheet, the blisters being in radial and concentric arrangement tocorrespond with the arrangement of apertures in the base, such blistersand the thereby defined portions of the thin sheet providing a pluralityof chambers, the said chambers being in registration with the aperturesin the base;

(g) a pharmaceutical tablet within at least one of the chamberswherefrom such tablet, via the aperture with which such chamber is inregistration, may be expressed by applying to the blister portion ofsuch chamber external force sufficient to rupture the portion of thethin disc defined by such blister portion; and

(h) an imprinted key on the thin sheet indicating the first table to bedispensed.

5. In conjunction with a metal foil disc bearing a number ofpharmaceutical tablets contained in individual chambers comprisingerect, transparent, deformable blister elements and frangible portionsof the metal foil disc circumscribed by such blister elements, whichchambers are concentrically and radially arranged, a device for theprogrammed dispensing of such tablets comprising.

(a) a base providing a raised peripheral portion and having a circularcentral recess and a plurality of concentrically and radially arrangedapertures therein corresponding with the arrangement of the chambers onthe said disc;

(b) chronologic indicia of sequence and periodicity on the peripheralportion of the base referable to the apertures;

- (c) a retaining member, centrally situated in the circular centralrecess of and integrally formed with the base, comprising a short postportion and an overhang portion adapted to receive the metal foil discabout the post portion thereof, to enable the metal foil disc to berotated-and selectively positioned with respect to the chronologicindicia, and to retain the metal foil disc close to the base by means ofthe overhang portion thereof; and,

(d) pegs on the base to fix the metal foil disc in the selectedplacement with respect to the chronologic 7 8 indicia, With the chambersthereof proximate and in respect to the chronologic datum, and to retainthe registration with the apertures in the base. metal foil sheet closeto the base by means of the 6. In conjunction with a metal foil sheet,having a overhang portions thereof; and, plurality of peripheralindentations and bearing a num- (d) projections on the base, extendinginwardly from her of pharmaceutical tablets contained in individual 5the raised peripheral portion thereof and cooperatchambers comprisingerect, transparent, deformable blising with the indentations of themetal foil sheet, to ter elements and frangible portions of the metalfoil sheet hold the metal foil sheet in the selected placementcircumscribed by such blister elements, which chambers with respect tothe chronologic datum, with the are concentrically and radiallyarranged, a device for the chambers thereof in registration With theapertures programmed dispensing of such tablets comprising 10 in thebase.

(a) a base providing a raised peripheral portion and having a centralrecess and a plurality of concen- References Cited by the Examinertrically and radially arranged apertures therein eor- UNITED STATESPATENTS gi gi gf fig i arrangement of the chambers 15 1,240,026 9/1917Chapman 206 42 (b) a chronologic datum for indication of sequence and2317860 4/1943 Sorensen 206 42 periodicity on the peripheral portion ofthe base 30545O3 9/1962 Hartman et 206-412 3,143,207 8/1964 Wagner206-42 referable to the apertures; (c) a retaining member, centrallysituated in the cen- 3199489 8/1965 Ruoss 20642 tral recess Of andintegrally formed With the base, 20 THERON E. CONDON, Primary Examinecomprrsrng a post portion and overhang portions adapted to receive themetal foil sheet about the post LOUIS MANCENE Exammer' portion thereofand to be selectively positioned with W. T. DIXSON, Assistant Examiner.

3. A DISPENSING CONTAINER FOR A SOURCE OF PHARMACEUTICAL TABLETSCOMPRISISNG, IN COMBINATION, (A) A BASE HAVING A RAISED OUTER PORTIONAND HAVING A CENTRAL CIRCULAR RECESS AND A PLURALITY OF APERTURESTHEREIN, SUCH APERTURES BEING ARRANGED, RADIALLY AND CONCENTRICALLY, INGROUPS; (B) CHRONOLOGIC INDICIA OF SEQUENCE AND PERIODICITY ON THERAISED OUTER PORTION OF THE BASE RESPECTIVELY PROXIMATE AND REFERABLE TOEACH GROUP OF APERTURES IN RADIAL ARRANGEMENT; (C) A CENTRAL RETAININGMEMBER COMPRISING POST AND OVERHANG PORTIONS IN THE CIRCULAR RECESS ANDINTEGRALLY FORMED WITH THE BASE; (D) A DISC, OF FRANGIBLE MATERIAL,HAVING A CENTRAL HOLE THEREIN, ADAPTED TO BE RECEIVED ABOUT THE POSTPORTION OF THE CENTRAL RETAINING MEMBER AND SELECTIVELY EMPLACED IN THECIRCULAR RECESS WITH RESPECT THE CHRONOLOGIC INDICIA AND TO BE RETAINEDON THE BASE BY THE OVERHANG PORTION OF THE CENTRAL RETAINING MEMBER; (E)A PLURALITY OF ERECT DEFORMABLE BLISTERS ON ONE FACE OF THE THIN DISC,THE BLISTERS BEING IN RADIAL AND CONCENTRIC ARRANGEMENT TO CORRESPONDWITH THE ARRANGEMENT OF APERTURES IN THE BASE, SUCH BLISTERS AND THETHEREBY DEFINED PORTIONS OF THE THIN DISC PROVIDING A PLURALITY OFCHAMBERS; (F) PEG MEANS ON THE BASE TO FIX THE THIN DISC IN THE SELECTEDPOSITION WITH RESPECT TO THE CHRONOLOGIC INDICIA AND THE CHAMBERS OF THETHIN DISC IN REGISTRATION WITH THE APERTURE IN THE BASE; (G) APHARMACEUTICAL TABLET WITHIN AT LEAST ONE OF THE CHAMBERS WHEREFROM SUCHTABLET, VIA THE APERTURE WITH WITH SUCH CHAMBER IS IN REGISTRATION, MAYBE EXPRESSED BY APPLYING TO THE BLISTER PORTION OF SUCH CHAMBER EXTERNALFORCE SUFFICIENT TO RUPTURE PORTION OF THE THIN DISC DEFINED BY SUCHBLISTER PORTION; AND (H) AN IMPRINTED KEY ON THE THIN DISC INDICATINGTHE FIRST TABLET TO BE DISPENSED.